As the Supreme Court deliberates the constitutionality of the Affordable Care Act, there are several key provisions unrelated to the individual mandate or the commerce clause that hang in the balance. One such provision can be found in the subtitle of the law known as the Biologics Price Competition and Innovation Act or BPCIA. This provision granted the U.S. Food and Drug Administration (FDA) the authority to approve imitative versions of biologic drugs, known as biosimilars, that would be less costly than the innovator biologic they attempt to replicate.

Generic forms of many standard, chemically produced drugs have been available in the United States for nearly three decades, offering patients less expensive alternatives to name-brand products. However, due to their complexity, biologics were excluded from the original legislation controlling the production and distribution of generic drugs in the U.S.

Biologics are a category used to describe medicines made from complex mixtures of proteins, sugars and nucleic acids. They are engineered in living organisms to treat serious illnesses including cancer, Multiple Sclerosis and HIV/AIDs. Unlike generic forms of chemically produced drugs, which are near exact copies of innovator products, a biosimilar can never be identical to its biologic. Any small difference in the structure or make-up of a biosimilar in relation to its innovator counterpart can also affect their safety and efficacy.

Recognizing the immense task ahead, the FDA met with industry, patient groups and researchers in late 2010 and released draft guidelines for biosimilar manufacturers this past February. The agency is now seeking additional input. The biggest area where input is needed is in ensuring biosimilars are safe and effective. Whereas innovator products are tested thoroughly in Phase 3 clinical trials, biosimilars may not have to go through the same rigorous clinical and analytical assessments. Requiring clinical studies, transparent product labels, unique names and other traceability measures will help put patients’ safety first.

Biosimilars are already available in the European Union and Canada, and we should learn from their experiences. For instance, these drugs are only available as standalone therapies and aren’t interchangeable with a biologic. They are not considered interchangeable in large part because there is so little known about how they interact with other drugs. While the FDA has the authority to determine a biosimilar “interchangeable” early indications are that it will not take that responsibility lightly and will issue additional guidance to set the parameters for such a determination.

As the Supreme Court deliberates on matters unrelated to biologics, the FDA continues to do what the Affordable Care Act required of it, i.e., help make sure that patients in the U.S. have access to biosimilars that are first and foremost safe but also more affordable. We can only hope that the Supreme Court decision is limited to the provisions that raise constitutional questions and those provisions that are constitutionally sound, good for patients and enjoy overwhelming bi-partisan support remain the law of the land.